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AAMI CR513
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2024
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Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing
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AAMI TIR48
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2024
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Quality Management System (QMS) Recommendations on the Application of the U.S. FDA___s CGMP Final Rule on Combination Products
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AAMI TIR99
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2024
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Processing of dilators, transesophageal and ultrasound probes in health care facil ities
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AAMI ST24
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2024
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Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
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AAMI 11140-6
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2024
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Steril ization of health care productsù Chemical indicatorsùPart 6: Type 2
indicators and process challenge devices for use in performance testing of small steam sterilizers
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AAMI TIR63
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2023
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Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
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